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To Evaluate the Safety and Clinical Radiological Outcomes in 2 Years of Embrance Model Reverse Shoulder Arthroplasty

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary completion date: Mar 24, 2024 to Oct 31, 2026
    • Study completion date: Mar 24, 2026 to Oct 31, 2026
    • Study description expanded, about 92 words
    • Study title revised
    v3
  2. Re-verified, no change to tracked fieldsv2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The use of inverted prostheses to replace shoulder joints damaged by degenerative or traumatic processes has become widespread over the past three decades. Current designs, used correctly, can restore function and improve pain in the majority of patients in whom they are implanted. The aim is to carry out a more detailed follow-up of the subjects who are implanted with this prosthetic model on a primary basis, analysing the clinical and radiological results and evaluating the presence of adverse effects of the prosthesis or short-term complications. For this purpose, subjects will be closely monitored for two years.
Trial Details
NCT Number NCT05569161
Lead Sponsor Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Conditions
(from sponsor)		 Implantation of a Reverse Shoulder Prosthesis
Enrollment 250 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov